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Prostate AdenocarcinomaPhase 2NCT07025369

Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With High Risk or Very High Risk Prostate Cancer, The EnrichPSMA Trial

A Phase 2 study testing Biospecimen Collection, Computed Tomography and Flotufolastat F-18 Gallium in people with Prostate Adenocarcinoma and Stage IIC Prostate Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

This phase II trial studies how well a short course of androgen deprivation therapy (ADT) with relugolix works in increasing expression of prostate-specific membrane antigen (PSMA) and improving diagnostic imaging with PSMA positron emission tomography (PET)/computed tomography (CT) in patients with high risk or very… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Biospecimen Collection, Computed Tomography and Flotufolastat F-18 Gallium
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
25 Aug 2025to 31 Mar 2029
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Histological confirmation of prostate adenocarcinoma
  • Diagnosis of high risk or very high risk prostate cancer per National Comprehensive Cancer Network (NCCN) Risk Stratification. [Any of the following: grade group 4 or 5, prostate-specific antigen (PSA) greater than 20, radiographic cT3 on MRI]
  • Testosterone greater than or equal to 300
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
  • Hemoglobin ≥ 9.0 g/dL (obtained ≤ 120 days prior to registration/randomization)
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  • Absolute neutrophil count (ANC) ≥ 1500/mm^3 (obtained ≤ 120 days prior to registration/randomization)
  • Platelet count ≥ 100,000/mm^3 (obtained ≤ 120 days prior to registration/randomization)
  • Male patients who are committed to undertaking the following measures for the duration of the study and after the last dose of ORGOVYX (relugolix) for the time period specified:
  • Use a condom during sex while being treated and for 30 days after the last dose of ORGOVYX (relugolix)
  • Do not make semen donations during treatment and for 30 days after the last dose of ORGOVYX (relugolix)
  • Those with female partners of childbearing potential may be enrolled if they are:
  • Documented to be surgically sterile (i.e., vasectomy);
  • Committed to practicing true abstinence during treatment and for 30 days after the last ORGOVYX (relugolix) dose; or
  • Committed to using an effective method of contraception with their partner during treatment and for 30 days following the last dose of ORGOVYX (relugolix)
  • Provide written informed consent

Who cannot join

  • Any of the following prior therapies:
  • Chemotherapy ≤ 2 weeks prior to registration/randomization
  • Androgen deprivation therapy
  • Pelvic radiation
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Uncontrolled intercurrent illness including, but not limited to:
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  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Or psychiatric illness/social situations that would limit compliance with study requirements
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  • Other active malignancy ≤ 1 year prior to registration
  • EXCEPTIONS: Non-melanotic skin cancer
  • NOTE: If there is a history of prior malignancy, they must not be receiving other active treatment for their cancer
  • History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
  • Use of P-glycoprotein inhibitors

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Referral Office contact

855-776-0015

mayocliniccancerstudies@mayo.edu

United States1 site, 1 recruiting

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Jack R. Andrews, MD

    Recruiting

Other trials in United States

About this study

Official title: Phase 2 Randomized Study to Assess Use of Androgen Deprivation to Enrich PSMA Expression and Improve Sensitivity of Staging PSMA PET/CT: The EnrichPSMA Trial

This phase II trial studies how well a short course of androgen deprivation therapy (ADT) with relugolix works in increasing expression of prostate-specific membrane antigen (PSMA) and improving diagnostic imaging with PSMA positron emission tomography (PET)/computed tomography (CT) in patients with high risk or very high risk prostate cancer. PSMA PET/CT has become the standard of care in imaging for high-risk prostate cancer. However, a limitation of PSMA PET/CT is its ability to detect cancer that has spread to the lymph nodes. PSMA is a protein that is usually found on the surface of normal prostate cells but is found in higher amounts on prostate tumor cells. Studies have shown that expression of PSMA is regulated by androgens (male reproductive hormones). Relugolix binds to gonadotropin-releasing hormone receptors in the pituitary gland, which blocks the pituitary gland from making the hormones follicle-stimulating hormone and luteinizing hormone. This causes the testicles to stop making testosterone. Relugolix may stop the growth of tumor cells that need testosterone to grow. PSMA PET/CT is an imaging procedure that is used to help find prostate tumor cells in the body. For this procedure, a cell-targeting molecule linked to a radioactive substance (flotufolastat F 18 in this trial) is injected into the body and travels through the blood. It attaches to PSMA that is found on the surface of prostate tumor cells. PET/CT scanners detect high concentrations of the radioactive molecule and shows where the prostate tumor cells are in the body. Giving a short course of ADT with relugolix may increase PSMA expression to detect smaller areas of prostate cancer that were not previously detected.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Comparison of maximum standard uptake value (SUVmax) and SUVmean values of the dominate primary prostate lesion between pre and post androgen deprivation therapy (ADT) imaging using flotufolastat F-18 gallium (POSLUMA [flotufolastat F 18]) PET/CT.

SECONDARY OBJECTIVES:

  1. Evaluate and compare the lymph node sensitivity between pre and post ADT imaging using POSLUMA (flotufolastat F 18) PET/CT.

II. Comparison of lymph node prostate-specific membrane antigen (PSMA) avidity between pre and post ADT imaging using POSLUMA (flotufolastat F 18) PET/CT.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM A: Patients receive flotufolastat F 18 and undergo PET/CT on day 0. Patients then receive relugolix orally (PO) once daily (QD) on days 1-5 in the absence of disease progression or unacceptable toxicity. Patients also receive flotufolastat F 18 and undergo PET/CT on day 5. Patients then undergo robotic radical prostatectomy with pelvic lymph node dissection within 90 days of 2nd flotufolastat F 18 PET/CT scan. In addition, patients undergo collection of blood samples throughout the study.

ARM B: Patients receive flotufolastat F 18 and undergo PET/CT on day 0. Patients then receive relugolix PO QD on days 1-10 in the absence of disease progression or unacceptable toxicity. Patients also receive flotufolastat F 18 and undergo PET/CT on day 10. Patients then undergo robotic radical prostatectomy with pelvic lymph node dissection within 90 days of 2nd flotufolastat F 18 PET/CT scan. In addition, patients undergo collection of blood samples throughout the study.

ARM C: Patients receive flotufolastat F 18 and undergo PET/CT on day 0. Patients then receive relugolix PO QD on days 1-15 in the absence of disease progression or unacceptable toxicity. Patients also receive flotufolastat F 18 and undergo PET/CT on day 15. Patients then undergo robotic radical prostatectomy with pelvic lymph node dissection within 90 days of 2nd flotufolastat F 18 PET/CT scan. In addition, patients undergo collection of blood samples throughout the study.

Being tested
Biospecimen Collection, Computed Tomography, Flotufolastat F-18 Gallium, Laparoscopic Radical Prostatectomy with Robotics, Pelvic Lymphadenectomy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo collection of blood samples

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo PET/CT

  • Flotufolastat F-18 GalliumOther

    Also called (18F)-rhPSMA-7.3, 18F-rhPSMA-7.3, 18FrhPSMA-7.3, F-18-rhPSMA-7.3

    Given flotufolastat F 18

  • Laparoscopic Radical Prostatectomy with RoboticsProcedure or surgery

    Also called RARP, Robot-assisted Radical Prostatectomy

    Undergo robotic assisted radical prostatectomy

  • Pelvic LymphadenectomyProcedure or surgery

    Also called Excision Pelvic Lymph Nodes, Pelvic Lymph Node Dissection

    Undergo pelvic lymph node dissection

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

  • RelugolixDrug

    Also called N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea, Orgovyx, Relumina, TAK 385

    Given PO

Study groups in NCT07025369
Study groupRoleWhat they receive
Arm A (5 days of relugolix, flotufolastat F 18 PET/CT)ExperimentalPatients receive flotufolastat F 18 and undergo PET/CT on day 0. Patients then receive relugolix PO QD on days 1-5 in the absence of disease progression or unacceptable toxicity. Patients also receive flotufolastat F 18 and undergo PET/CT on day 5. Patients then undergo robotic radical prostatectomy with pelvic lymph node dissection within 90 days of 2nd flotufolastat F 18 PET/CT scan. In addition, patients undergo collection of blood samples throughout the study.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Flotufolastat F-18 Gallium; Procedure: Laparoscopic Radical Prostatectomy with Robotics; Procedure: Pelvic Lymphadenectomy; Procedure: Positron Emission Tomography; Drug: Relugolix
Arm B (10 days of relugolix, flotufolastat F 18, PET/CT)ExperimentalPatients receive flotufolastat F 18 and undergo PET/CT on day 0. Patients then receive relugolix PO QD on days 1-10 in the absence of disease progression or unacceptable toxicity. Patients also receive flotufolastat F 18 and undergo PET/CT on day 10. Patients then undergo robotic radical prostatectomy with pelvic lymph node dissection within 90 days of 2nd flotufolastat F 18 PET/CT scan. In addition, patients undergo collection of blood samples throughout the study.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Flotufolastat F-18 Gallium; Procedure: Laparoscopic Radical Prostatectomy with Robotics; Procedure: Pelvic Lymphadenectomy; Procedure: Positron Emission Tomography; Drug: Relugolix
Arm C (15 days of relugolix, flotufolastat, F 18 PET/CT)ExperimentalPatients receive flotufolastat F 18 and undergo PET/CT on day 0. Patients then receive relugolix PO QD on days 1-15 in the absence of disease progression or unacceptable toxicity. Patients also receive flotufolastat F 18 and undergo PET/CT on day 15. Patients then undergo robotic radical prostatectomy with pelvic lymph node dissection within 90 days of 2nd flotufolastat F 18 PET/CT scan. In addition, patients undergo collection of blood samples throughout the study.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Flotufolastat F-18 Gallium; Procedure: Laparoscopic Radical Prostatectomy with Robotics; Procedure: Pelvic Lymphadenectomy; Procedure: Positron Emission Tomography; Drug: Relugolix

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum standard uptake value (SUVmax) for pre and post androgen deprivation therapy (ADT) prostate-specific antigen (PSMA) positron emission tomography (PET)

    Will be compared in all patients (pooled across randomization groups). We will explore differences between 5, 10 and 15 days since ADT initiation as hypothesis-generating, but the study will not be powered to detect differences between these groups.

    Measured: Day 0 up to day 15

  2. Mean standard uptake value (SUVmean) for pre and post ADT PSMA PET

    Will be compared in all patients (pooled across randomization groups). We will explore differences between 5, 10 and 15 days since ADT initiation as hypothesis-generating, but the study will not be powered to detect differences between these groups

    Measured: Day 0 up to day 15

Secondary outcomes (3)

  1. Lymph node sensitivity of the pre and post ADT PSMA PET with surgical pathology as standard of truth

    Accuracy of imaging results (pre/post) for identifying either pelvic nodal or distant metastatic disease will be evaluated versus pathology result (standard of care). The reference standard regarding the presence of pelvic nodal or distant metastases will be determined by histopathologic findings.

    Measured: Day 0 up to day 15

  2. Lymph node PSMA avidity between pre and post ADT PSMA using flotufolastat F 18 PET/computed tomography (CT)

    Accuracy of imaging results (pre/post) for identifying either pelvic nodal or distant metastatic disease will be evaluated versus pathology result (standard of care).

    Measured: Day 0 up to day 15

  3. Incidence of adverse events (AEs)

    Assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.The maximum grade for each type of AE will be recorded for each patient.

    Measured: Up to 90 days following 2nd PSMA PET/CT (end of treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2025
  2. Study start25 Aug 2025
  3. Primary completion1 Jan 2029 (estimated)
  4. Study completion31 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07025369
Sponsor's protocol ID
MC240503
Other IDs
NCI-2025-03965, 25-002008, MC240503
Status last verified
Sep 2026
First submitted
9 Jun 2025
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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